Job Title: Drug Safety Associate
Company: GSS Pharma Pvt. Ltd.
Location: Bangalore Urban, India
Role Description:
We are seeking a full-time, on-site Drug Safety Associate to join our team at GSS Pharma Pvt. Ltd. in Bangalore Urban. The Drug Safety Associate will be responsible for various Pharmacovigilance activities, including:
- Assisting the Qualified Person for Pharmacovigilance (QPPV)
- Conducting global literature monitoring
- Performing data entry and quality reviews
- Engaging in signal detection and evaluation
- Preparing regulatory documents
Key Responsibilities:
- Thorough understanding of current global Pharmacovigilance guidelines and procedures
- Prioritizing cases based on day zero and seriousness, ensuring timely completion as per client SOPs
- Verifying data accuracy captured by case registration/import associates
- Performing duplicate checks during case processing to identify inconsistencies
- Downloading and processing literature reports and line listings
- Reviewing and assessing the validity of literature abstracts and articles, processing them into the safety database as required
- Downloading and processing Individual Case Study Reports (ICSR) and line listings
- Conducting MedDRA coding
- Monitoring Pharmacovigilance Risk Assessment Committee (PRAC) recommendations and implementing updates
- Managing worldwide scientific literature, including screening and processing reports
- Ensuring compliance with regulatory and local/global SOP timelines through proactive workflow management
- Representing Drug Safety in regulatory and internal inspections and audits as needed
Qualifications:
- Proficiency in Narrative, Medical Coding, and Pharmacy skills
- Doctor of Pharmacy (Pharm D)
- Excellent attention to detail
- Strong knowledge of Pharmacovigilance regulations and requirements
- Superior written and verbal communication skills
- Experience in Pharmacovigilance or a related role is a plus